722 Human Recombinant Factor VII for Emergency Reversal of Coagulopathy in Neurosurgical Patients

INTRODUCTION: Severe coagulopathy in neurosurgical patients is a common and serious problem. The mainstay of emergency therapy is fresh-frozen plasma (FFP) and vitamin K. These are not always rapid enough. Recently, human recombinant factor VII has been used to reverse coagulopathy, but data are still limited on its safety and efficacy. METHODS: We report the use of factor VII to reverse coagulopathy in 29 neurosurgical patients (FVII group); 24 other patients treated before introduction of factor VII, or who received no factor VII because of physician preference, served as controls. Factor VII was used a second-line therapy after initial attempts at reversal with FFP had failed. RESULTS: There were no significant differences in baseline variables between the groups (P > 0.5): FVII versus controls: age 60 versus 57 years, 55% versus 58% male, 14 of 29 (48%) versus 9 of 24 (38%) with warfarin-induced coagulopathy, 20 of 29 (69%) versus 17 of 24 (71%) presented with intracranial hemorrhage. The mean international normalized ratio (INR) upon admission was 2.33 versus 2.15 (P < 0.5). After initial FFP, before administration of factor VII, INR decreased to 1.67 ± 0.18 (mean ± standard error of the mean) in the FVII group and 1.85 ± 0.22 in controls. INR tended to rise again rapidly after the initial infusion of FFP in both groups and in the FVII group was back to a mean of 2.20 before factor VII administration. In this group, 1.2 mg of factor VII resulted in immediate normalization of INR to a mean of 1.12 (P < 0.05). Three of 29 (10%) in the FVII group and 4 of 24 (17%) of the control group died. One patient in the control group developed deep vein thrombosis; there were no thrombotic complications in the FVII group. CONCLUSION: Factor VII seems to be safe and highly effective when emergency reversal of coagulopathy is desired in neurosurgical patients. We speculate that the use of factor VII as first-line therapy may expedite normalization of INR and result in decreased use of FFP.